The following is a transcript of an interview with Dr. Scott Gottlieb, which aired on Sunday, May 15, 2022, on Face the Nation.

MARGARET BRENNAN: And now we turn to Dr. Scott Gottlieb, former FDA Commissioner Trump and member of the Pfizer board. Good morning to you, doctor.

DR. Scott GOTLIB: Good morning.

MARGARET BRENAN: I want to touch on your perspective as a person who has run the FDA. You have just heard the opinion of the administration that this lack of baby formula is a failure of one company and that the FDA is not necessarily fully responsible for ensuring the affairs of this plant. I wonder how you react to that.

DR. GOTLIB: Well, these were constant problems that seemed to be poorly addressed by the company. The FDA did not exercise all the control they could have over this facility. There have been known problems with this facility dating back many years or the results of previous inspections. The agency had in its hands a 34-page report of the informant, which contained quite serious allegations of data falsification and information on data falsification concealed from inspectors. Therefore, they should have caused more aggressive actions earlier. I think now this facility has been closed by Abbott and production is not continuing. It will be difficult to clean the object. The allegations of data falsification will be those allegations that are difficult for the agency to find out. Even if they are unable to prove a causal link between the infections we have seen in children and the very means by which the agency has not yet been able to prove it, they may never be able to prove it.

MARGARET BRENAN: Mmmm. You just said the FDA didn’t do everything it could. We know they didn’t inspect the Abbott facility back in 2020. During the pandemic, they stopped inspecting some places that were not critical. Isn’t baby formula critical? How does the facility not pass FDA verification?

DR. GOTLIB: Well, look, this is critical, and during the shutdown of the government, we actually kept inspections of baby formula plants because of the risks associated with these facilities …

MARGARET BRENAN: When you were in office.

DR. GOTLIB: – Probably, it was necessary to check, especially – when I was in office – especially given the fact that there were preliminary conclusions. The fact that this year the FDA went into the facility and identified five different strains of Cronobacter is a matter of serious concern. It seems that this was not a modern institution based on the findings in 483. Therefore, they had to be under close supervision. Look, we now have the worst of both worlds. We have a fairly rigid regulatory scheme that creates barriers for new entrants to enter the market. Over the past 15 years, there has been only one new entrant, a domestic manufacturer, a memory company. But at the same time, it does not provide strict enough control over the resulting oligopoly. Three companies control 80% of the market to ensure that there are no errors that could cause the cessation of these facilities. And so when you have a shutdown when the market is so focused, it creates these distributed deficits that we are witnessing now and that are very difficult to solve. Eventually they will need to restore this facility. The timing of this moment is very uncertain.

MARGARET BRENNAN: And that’s what I wanted to ask you. I’m sure the FDA commissioner will be questioned about this on Capitol Hill this week. But you said the market is broken and you point to regulatory failures. An informant’s report said they were unable to keep proper records and released an untested infant formula. There are all sorts of accusations. Do you think this is criminal?

GOTLIB: Potentially. And this informant’s report was sent to the head of the FDA’s Office of Criminal Investigations. So it seems like a complicated informer. Remember, there are nine people in this FDA department, and when I was there, there were even fewer. In recent years it has grown and we have made some budget requests to increase the size of this group. Thus, the entire industry in this country is overseen by nine people. It has been part of an agency with insufficient resources for a very long time, and this, I think, contributes to these challenges that the agency is facing in trying to exercise more vigorous and effective oversight. Yes, these allegations will be very difficult to clear. And another problem may be that the people whose informant was involved with the FDA were interviewing that informant, perhaps the same people who are now making statements to the agency about the security of that facility. And if so, it will complicate matters.

MARGARET BRENAN: As always, we have something to talk about with you. So stay with us. And on the other side of the break we will continue the conversation. So stay tuned to Face the Nation.


MARGARET BRENNAN: Welcome to Face the Nation. Now we want to continue working with former FDA Commissioner and Pfizer board member Dr. Scott Gottlieb. Dr. Gottlieb, we talked about the lack of baby formulas. I want to ask you about COVID, but just to understand what you said, I think you told me that in this country only nine people oversee the entire infant formula industry. Nine?

GOTLIB: That’s right. And I think I think there were three of them when I started working for the FDA. We got a few more resources for this group. More resources have been added since then, and the current administration has asked to add four more people. But yes, only nine people now oversee, oversee the entire industry in the United States. And just a few years ago it was less.

MARGARET BRENAN: It’s weird. Let me ask you about COVID. This week we had this horrible milestone – 1 million deaths during the entire pandemic. We now have an average of about 326 deaths a week. So we went far. But this week we heard from Dr. Foci and Dr. Valensky that they started wearing masks when they entered the room. Once again, there are concerns about growth. What do you see in terms of trend lines? Where are we?

GOTLIB: Well, look, we’re definitely seeing an outbreak of infection, especially in the northeast and parts of the Mid-Atlantic. If you look at the simulations that are happening in these states such as Connecticut, New York, it seems that now is the peak of the infection. This is mainly a wave of infection caused by B.2 and this new version of Omicron B.2.12.1, which appears to be more contagious and has more immunity than previous versions of Omicron. It seems that most people who become infected are not people who were previously infected with B 1. But some of the 40% of people who escaped the previous Omicron wave are now falling under that wave. I believe that the cases will decrease. Data on wastewater collected in cities show that the overall incidence is declining and that we should not have a big wave of infection this summer. Although there are models around the administration, this summer it is showing a big wave of infection. The bottom line is that we didn’t see it in 2020. We didn’t see this in 2021 when B117 appeared in the spring. So this summer should be a protection against the further spread of this option, but it poses a risk for the fall. And it will be important to know whether the new vaccines currently being developed will well cover this B2 option. Hopefully there will be. I believe they will, but it remains to be seen.

MARGARET BRENNAN: So you reject the idea of ​​a summer surge, even if scientists like Dr. Birks, who participated in this program just a few weeks ago, predict and see a trend line that raises her very concern about what might happen because it happened before.

GOTLIB: Yes. And there’s a model that the White House was informed about last week that shows a big spike in summer infection caused by B2 when it moves to the Midwest and West. I mean, it’s certainly possible, but other people disagree with this model. There is a chance that you will see a slow burn during the summer. I think you are more likely to see the level of infection go down. Remember, we thought last year and this summer would be a big surge with the B117 when it came out in the spring. And when we got to next spring, the infection rate dropped. In July we had a relatively quiet June, and then in late August the Delta appeared and started creating a new wave of infection. I think this is probably the picture we will see again when in June, July, relatively low people feel safe again. And then when we head out in late summer, B.2.12.1 will probably appear or B2 mostly in the south.

MARGARET BRENAN: Dr. Gottlieb, we will watch this. Thanks for your understanding as always.

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